March 21, 2017

Teriflunomide Oral tablet

What is this medicine?

TERIFLUNOMIDE (TER i FLOO noe mide) treats multiple sclerosis. It can decrease the number of flare-ups. This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • diabetes

  • have a fever or infection

  • high blood pressure

  • immune system problems

  • kidney disease

  • liver disease

  • low blood cell counts, like low white cell, platelet, or red cell counts

  • lung or breathing disease, like asthma

  • recently received or scheduled to receive a vaccine

  • receiving treatment for cancer

  • skin conditions or sensitivity

  • tingling of the fingers or toes, or other nerve disorder

  • tuberculosis

  • an unusual or allergic reaction to teriflunomide, leflunomide, other medicines, food, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often that directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • leflunomide

This medicine may also interact with the following medications:

  • alosetron

  • birth control pills

  • caffeine

  • certain medicines for diabetes like repaglinide, rosiglitazone, pioglitazone

  • certain medicines that treat or prevent blood clots like warfarin

  • charcoal

  • cholestyramine

  • duloxetine

  • live virus vaccines

  • medicines that lower your chance of fighting infection

  • paclitaxel

  • theophylline

  • tizanidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

This medicine may stay in your body for up to 2 years after your last dose. Tell your doctor about any unusual side effects or symptoms.A medicine can be given to help lower your blood levels of teriflunomide quickly.

Women must use effective birth control with this medicine. There is a potential for serious side effects to an unborn child. Do not become pregnant while taking this medicine or for 2 years after stopping it. Inform your doctor if you wish to become pregnant. This medicine remains in your blood after you stop taking it. You must continue using effective birth control until the blood levels have been checked and they are low enough. Immediately talk to your doctor if you think you may be pregnant. You may need a pregnancy test. A medicine can be given to help lower your blood levels of this medicine more quickly. Talk to your health care professional or pharmacist for more information.

For men, your partner should not become pregnant while you are taking this medicine. There is a potential for serious side effects to an unborn child. You and your female partner should use effective birth control during your treatment. This medicine is found in the semen of men. This medicine remains in your blood after you stop taking it. Men who wish to father a child should continue using effective birth control until the blood levels of this medicine have been checked and they are low enough.

You should not receive certain vaccines during your treatment and for 6 months after your treatment with this medication ends.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • dizziness

  • low blood counts - this medicine may decrease the number of white blood cells and platelets. You may be at increased risk for infections and bleeding.

  • pain, tingling, numbness in the hands or feet that is different from your multiple sclerosis symptoms

  • redness, blistering, peeing or loosening of the skin, including inside the mouth

  • signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in urine

  • signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine

  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

  • trouble passing urine or change in the amount of urine

  • vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • diarrhea

  • fatigue

  • hair thinning or loss

  • headache

  • nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 to 25 degrees C (68 to 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


March 21, 2017


U.S. FDA-approved Package Insert